BIVONA TRACHEOSTOMY TUBES

Tube Tracheostomy And Tube Cuff

SMITHS MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Bivona Tracheostomy Tubes.

Pre-market Notification Details

• Device ID: K083641
• 510k Number: K083641
• Device Name: BIVONA TRACHEOSTOMY TUBES
• Classification: Tube Tracheostomy And Tube Cuff
• Applicant: SMITHS MEDICAL ASD, INC. 5700 WEST 23RD AVE. Gary, IN 46406
• Contact: Daniel Coates
• Correspondent: Daniel Coates; SMITHS MEDICAL ASD, INC. 5700 WEST 23RD AVE. Gary, IN 46406
• Product Code: JOH
• CFR Regulation Number: 868.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-09
• Decision Date: 2009-02-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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